Apparatus for and method of preparing, storing, and dispensing fluids



May 3, 1938. c w, WALTER 2,116,132

APPARATUS FOR AND METHOD OF PREPARING, STORiNG, AND DISPENSING FLUIDSFiled March 4, 1936 2 Sheets-Sheet l May 3, 1938.

c. w.' WALTER APPARATUS FOR AND METHOD OF PREPARING, STORING, ANDDISPENSING FLUIDS Filed March 4, 1936 2 Sheets-Sheet 2 Invenior: 621?; WWaZZez". 38;,

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- Patented-.3, 193s PARING, FLUIDS STORING, AND DISPENSING Carl W.Walter, Newton, Mass. Application March 4. 1936, Serial No. 67,087

16 Claims.

My present invention relates to app 1 and methods of preparing,storingand utilizing fluids, more particularly in uses where anuncontaminated or sterile condition of the fluid is 5 important, as inthe medical and surgical fields.

While susceptible of more general use,'the apparatus and method of theinvention are especially adapted for the preparation, storage andadministration of parenteral fluids.

10 In the drawings, illustrating by way of ex- 'ample one apparatusembodying the invention, and by means of which the method thereof may bepractised,

Fig. 1 shows the apparatus as a whole;

15 Fig. 2 is a perspective of one element of the closure means, namelythe stopper, upon a larger scale;

Fig. 3 is a cross-section of a flexible, resilient bushing used in theapparatus;

2 Figs. 4 and 5 are sectional views, on substantially full scale,showing a portion of the apparatus in the preparation and storageconditions respectively; and

Fig. 6 is a sectional view on a similar scale as 5 Figs. 4 and 5 showinga portion of the apparatus in use, as in Fig. 1.

The production of a reliable supply of various fluids, includingparticularly parenteral fluids, in their localities of use, such asotherwise ad- -30 equately equipped hospitals, has heretofore beenhindered by the lack of simple methods and apparatus by means of whichchemically pure solutions and fluids can be prepared, stored and dispensed safely and economically. In accordance 35 with the meansand'methods of my present invention, this difficulty is obviated.

Referring more particularly to the drawings, and first to Fig. 1, theapparatus as a whole, as there illustrated by way of example, includesany 40 required number of vessels or flasks I for the reception of theparenteral or other fluid, and, for each flask, a tight fitting bushing8, a stopper or stopper element 9, a vent-tube or outlet element In, aflexible conduit II and the parenteral introductory means or needle it.

structure,v for cooperation with the stopperlng means.

The parenteral or other fluid to .be sterilized and stored for use isplaced in the flask I and the special bushing 8 is inserted in the flask6 mouth. As best seen in Fig. 3, showing such bushing beforeapplication, the latter includes a reducing or plug portion l5 and askirt l6 adapted to be turned down externally about the mouth of theflask. The bushing is formed of rubber, 10 rubber composition or othernon-toxic and heatresistant resilient material adapted to retain itsresiliency after repeated subjections to heat and to have hermeticsealing engagement with the flask. As shown, the bushing is providedwith a single central through aperture H for the alternate reception, atdifferent stages of the proc ess as a Whole, of the stem l8 of thestopper 9, and of the dipensing valve or vent-tube [0. The diameter ofthis single aperture, and hence of the stopper stem IB and the vent-tubeIll is desirably not greater than the thickness of the wall of the plugportion of the bushing. The inner or bottom face of the bushing may bevariously formed, either dished as indicated at ll or otherwise. Thebushing and stopper proper 9 in combination constitute stopperingmeans". for the flask, and the bushing in conjunction with the vent-tubel0 cooperates as releasing or dispensing means. I r

The stopper 9 in accordance with the invention is composed of a materialwhich not only is non-corrosive and chemically resistant but also iscapable of effective sealing but non-sticking engagement with thebushing. Accordingly, as a result of extensive experiment, I employ inthe preferred embodiment a stainless steel, for example, Carpenter Group4 stainless steel, which actual practice has proven to be highlysatisfactory for the purpose. Within the contemplation of the invention,however, other metallic or non-metallic materials may be used providedthey possess the desired properties of non-corrosiveness, lack ofharmful reaction with the rubber or composition of the bushing,non-adhesiveness 5 therewith to any objectionable extent, even atstantially flat base or cover portion of-an area corresponding to thatof the bushing 8 when positioned with its skirt down-turned as in Figs.4, 5 and 6, and a peripheral flange 20 with outturned lip 21substantially as illustrated, the flange being receivable over thedown-turned skirt of thebushing and extending substantiallydownwardlyover it. The neck of the flask, the bushing and the stopper areproportioned and arranged to fit snugly with respect to each other, asillustrated in Fig. 5, and in such manner asto form an hermetic sealunder the conditions to be described, which sealing action is increasedin the presence of negative pressure within the flask.

The stem ll of the stopper is provided with a longitudinal vent orchannel 22 for the constricted escape of air, steam or other gas whenthe stopperisinpartlyinsertedposition,asinl lg.4. This vent may bevariously formed, but for the purposes of simplicity and cleanliness isfashioned as an open channel'or groove of relatively smallcross-sectional area, as compared with that of the stem as a whole;Preferably it has a rounded bottom as indicated at 23, see Fig. 2, andsloping outwardly at its end nearer the cap, as at 23', Figsri and 5, toavoid corners or angles in which dirt might collect, and to make iteasier to clean. This channel 22 is formed in the lower portion of thestopper stem and is of a length desirably at least equal to the verticalcentral thickness of the plug portion I! of the bushing 8 'so that thechannel may provide a passage completely through the central'aperture llof the bushing when so desired, as during sterilization of the fluid.The stem has a totalv length, includingthe solid unchanneled portionbetween the channel 22 and the cap, of sufficient extent so that whenthe stopper is completely inserted, as in Fig. 5, the channel comeslargely or wholly beyond the inner end of the bushing and the aperturein the latter is effectively closed by the solid part of the stem.Accordingly, as will be noted from a comparison of Figs. 4 and 5, theover-all length of the stem desirably is at least approximately twicethe vertical length or thickness of the central part of the plug portionof the bushing. Obviously it is not essential that the channel 22 becartied to the extreme end of the stem if the latter is given a lengh inexcess of that necessary to the functions described, so long as the stemand channel are so proportioned andarranged with respect to the bushingas to provide for their venting,

and their sealing positions other.

The stopper stem and its channel desirably also are formed andproportioned for the purpose of affording an audible signal attendant onthe passage of air, steam or other gases through the channel, in eitherdirection, useful in a manner more fullyreferred to later. This audiblesound or signal is in the nature of awhistling action, dependent in parton the small cross-sectional size of the channel, having reference tothe gas pressure likely to bev available, and in some part on theconformation of the channel whereby the controlled passage of the air orother gas effects the desired whistling or signaling action. The freeend of the stopper stem may be rounded off or tapered, as indicated at24, to facilitate its insertion in the bushing. V

In the preparation of one form of parenteral fluid, fresh singlydistilled water is drawn from the available supply, preferably preparedespecially for the purpose. Isotonic sodium chloride solution,preferably of the strength 0.85%, is

with respect to each 300 c. c. "Pyrex" burette equipped with a cleanAfter the solution is complete,

rubber stopper. flfty cubic centimeters of this filtrate may then bemeasured into a counter-balanced 1500 c. c.

flask, such as the flask I here illustrated, distilled water being addedto a net weight of 1049 grams.

A clean bushing l is then fltted into the mouth.

of the flask. the skirt ll of the bushing is turned down, and the stemll of the stopper I is partially inserted, as shown in Fig. 4.

Each such flask with its partly inserted stopper is then subjected toheat treatment in any convenient manner, preferably in an autoclave orsterilizer, the recommended temperature and time being 250 F. for 20minutes. During the sterilising operation, the air, steam or other gasesfrom within the flask pass off through the channel 22 in the stopperstem, Following such period the steam supply to the autoclave is shutoff and the latter is permitted to cool to 180 F. before being opened.This avoids undesired concentration of the solution resulting from theebullition of steam which would follow a sudden release of pressure. Butif for any reason the sterilizer is prematurely opened and a resultantconcentrating effect upon the solution occurs, the steam or gas passingout through the stoppering means, then still elevated, produces theaudible signal or whistle previously referred to, and henceautomatically informs and warns that the solution has been spoiled forthe intended use. in such cases where excess concentration is dangerousor undesirable.

Where cooling within the sterilizer has been properly effected, absenceof an audible signaling effect at the stoppers of the flasks givesassurance that the concentration of the fluid has not been undulyincreased, and the flasks are ready for removal. Attendant on removal ofeach flask from the autoclave or sterilizer, its stopper I isimmediately pushed or driven home into the completely hermetic sealingposition as illustrated in Fig. 5. The nurse or operator mayconveniently do this with the palm of the hand applied only to the topof the stopper cap is, so that no portion of the apparatus which is tobe contacted by the fluid will be exposed or touched. The hermetic sealis effected by the close, pressure fit between the stopper and thedown-turned skirt of the bushing and between the latter and the neck ofthe flask. This sealing action is augmented and insured by the furthercooling of the contents of the flask, resulting in an internal negativepressure which effects an absolute sealing engagement between the partsreferred to. Pressure on the base of the bushing, whether the latter beconcave or otherwise, tends to spread the lower, plug portion of. thebushing. forcing it into intimate contact with the wall of the flaskneck.

This formation of a partial vacuum within the,

flask in the manner described is utilized for the additional importantfunction, at the time when the contents ofthe flask are to be used, ofinforming that such contents have remained in the desired sterilecondition. This is because subsepartial vacuum. If the nurse or operatorfails to receive the sound signal when the stopper is released, it isthen apparent that the fluid contents have not been properly sterilizedor have been tampered with. v

The vacuum or partial vacuum formed in the sealed flask as it cools, inthe manner previously" described, also servesthe additional function ofenabling a nurse or other person who has occasion to examine the flaskto determine immediately and without breaking the stoppering seal thatthe hermetic seal has been maintained and that accordingly the fluidcontents retain their sterile condition. The vacuum within the sealedflask normally is such as to afford a water hammer effect, so that bymerely tilting or jarring the flask sufllciently to move the fluidcontents a distinct ringing, knocking or hammering sound is produced,due to the contact of the fluid contents with the flask wall in thepresence of the negative pressure within the flask. Failure to note thissound effect when the fluid contents are disturbed may be considered asan indication that the sealing of the flask has been tampered with orhas failed for some reason and that the contents accordingly are unsafe.

Any required number of flasks containing solutions prepared andsterilized as described can be stored indefinitely without impairing thecontents of the flasks as safe parenteral fluids. The stoppering meansdescribed afi'ords an efficient and sterile seal, preserving the sterilecondition of the fluid indefinitely and in the original container, sothat it is instantly available for use by the clinician wheneverdesired.

when the fluid is to be administered it is but necessary to withdraw thestopper 9, checking the condition of the contents by means of theoccurrence or non-occurrence of the audible signal. Sounding'oi thesignal at thistime, it will be understood, is indicative of correctconditions,

whereas its occurrence at the earlier stage of the process as previouslydescribed signifies noncorrect conditions. That is, at the cooling stepit is a stop-warning, while at the fluid-administering stage it is aconfirmatory signal. A sterile vent-tube Ill is at once readily insertedin the bushing, the tube having removably attached to it a sterileflexible conduit or rubber hose II and the needle ii. A sufflcientsupply of sterile sets of such vent-tubes, rubber tubing and needlespreferably is kept at hand, one for each flask to be utilized.

As best s en in Fig. 6, the dispensing valve or vent-tube l comprises anelongated'tubular member having a main external diameter correspondingto that of the stem [8 of the stopper 9, and of the aperture ll of thebushing, so as to form a tight flt within the latter. This venttube maybe composed of. any suitable material capable 01'. heat sterilization,but preferably is,

such as the external rib or bead 21.

To provide for free gravity flow of the fluid from the flask the latteris inverted, and valve means is incorporated in the vent-tube i0 so asto permit the entrance of air sufficiently to counteract negativepressure within the flask. Accordingly, as illustrated, the tube ill isformed with a longitudinal air-inlet passage or duct 28 having an inletaperture 29 externally of the positioning head 21 and terminating at ornear the end of the tube opposite the nipple 25 in a small capillaryoriflce 30. The size of this oriflce is such that the surface tension ofthe liquid thereat is adequate to support the weight of the maximumcolumn of liquid within the flask above the orifice.

Outlet for the liquid contents of the flask is provided by means of thelarger oriflce 3| located at any convenient position in the main wall ofthe tube, and sufflciently spaced from the positioning bead 21 so thatsaid orifice comes within the flask and clear of the bushing 8 when thevent tube is inserted, as in Figs. 1 and 6.

In administering the fluid in accordance with the method and apparatusof my invention, a sealed flask with sterile contents, such as shown atthe lower right portion of Fig. 1, and in Fig. 5, has its stopperremoved, as in the manner indicated in Fig. 1. A sterile vent-tube ill,with clean tubing H and needle I2 attached, is immediately inserted inthe single aperture in the bushing, wherein it has a sealing flt due tothe described proportioning and construction of the apparatus as awhole. It will be noted that during such operation no surface to becontacted by the fluid need be engaged by the hand of the operator orattendant. Only the peripheral flange of the stopper need be engaged,while the inner end of the vent-tube engages only sterile portions ofthe bushing. The flask with inserted vent-tube is then inverted andsupported in any suitable manner to afford a gravity flow. For thispurpose I have found it convenient to use supporting means as shown inFig. 1, including a split collar or ring 35 attached to a hanger 36adapted to be hung on a hook or the like 31 on a transportable standardor other support 38.

From the foregoing it will be apparent that by use of the method andapparatus of my invention hospitals, clinics and the like are enabled toprepare parenteral and other fluids and solutions, to store the sameconveniently and in adequate quantity, and to administer the same fromthe original container, with all reasonable assurance of safety.

It will be understood that my invention, either as to means or as tomethod, is not limited to the exemplary embodiments or steps hereinillustrated or described, its scope being set forth in the followingclaims:

I claim:

1. An improvement in preparing, storing and utilizing parenteral andother fluids, which comprises, in combination; a heat-resistant flaskadapted to sustain an internal partial vacuum; a one-piece resilientnon-toxic and heat-resistant bushing for the mouth of the flask, saidbushing having a single cylindrical through aperture of substantiallyuniform diameter; a non-corrosive metal stopper cooperable with thebushing to afford an hermetic seal for the flask, said stoppercomprising a flanged cap adapted to seat on and enclose the upperportion of the bushing and the flask mouth and a cylindrical stem havinga sealing fit in the bushing aperture and provided with a restrictedpassage for gas in a portion of the stem spaced from the cap; and areadily sterilizable transparent, one-piece venting member ofsubstantially cylindrical external form adapting it fornon-contaminating reception in said aperture of the bushing, saidventing member ,having a caplllary valved longitudinally extend-'channel arranged to provide passage for gas in the partly insertedposition of .said element and to be completely blocked in the fullyinserted position thereof; and a dispensing tube also receivable insaid'bushing aperture interchangeably with said stopper element andadapted to extend through the bushing sufliciently to aflord acontrolled exit for the fluid from the container,

said tube having integrally incorporated internally thereof acapillary-valved passage for vacuum-relieving ingress of air and beingformed at its outer end for the attachment of a flexible conduit.

3. Fluid-handling apparatus comprising, in combination; a heat-resistantcontainer having a restricted mouth; a bushing fitting the containermouth and having a single through aperture, said bushing consisting in aone-piece element comprising a relatively thick-walled reducing or plugportion through which said aperture extends centrally, the latter havinga diameter not substantially exceeding the wall thickness of said plugportion, and a peripheral skirt above and adapted to be turned down soas to tightly enclose the flask mouth and upper end of the said plugportion, said bushing and flask mouth being mutually shaped andconstructed to resist undue inward movement of the positioned bushing inthe presence of a negative pressure within the flask, and said bushingbeing integrally formed of a flexible, resilient material which retainsits resiliency and otherwise withstands repeated subjection to heat andmoisture at sterilizing temperatures; a stopper element adapted to closesaid bushing aperture and having a restricted gas channel arranged toprovide passage for gas in the partly inserted. position of said elementand to be completely blocked in the fully inserted position thereof; anda dispensing tube also receivable in said bushing aperture and adaptedto extend through the bushing sumciently to afford a controlled exit forthe fluid from the container, said tube having integrally incorporatedtherewith a capillary-valved passage i'or vacuum-relieving ingress ofair and being formed at its outer end for the attachment of a flexibleconduit.

4. Fluid-handling apparatus comprising, in combination; a heat-resistantcontainer having a restricted mouth; a bushing of rubber compositionfitting the container mouth and having a single through aperture; astopper element adapted to close said bushing aperture, said stopperelement being composed entirely of stainless steel of a surface textureadapted to have sealing but non-adherent engagement with the rubbercomposition of said bushing and comprising a substantialy flat caphaving a down-turned peripheral flange and an elongated dependingcentral stem of relatively small diameter as compared with the cap andconforming to the bush-- nel of restricted cross-sectional area, thespacing of the channel from the cap being sumcient to provide forblocking the channel when the stopper cap is inserted flush with saidbushing; and a dispensing tube also receivable in said bushing apertureand adapted to extend through the bushing s'ufliciently to aiiord acontrolled exit for the fluid from the container, said tube havingintegrally incorporated therewith a capillaryvalved passage forvacuum-relieving ingress of air and being iormedat its outer end for theattachment of a flexible conduit.

5. Fluid-handling apparatus in accordance with claim 4 wherein thelongitudinal gas channel in the stopper stem has-a length, conformationand cross-sectional area whereby in the use hi the stopper the passageof gas under pressure the fluid in a container in a manner aflording arestricted gas exit and sterilizing the fluid in the container while sopermitting the escape of gas. sealing the container afte'r. sterilizingby completing the stoppering thereof so as to close the gas passage,substituting in the stoppering means a dispensing unit receivableinterchangeably in the place of the sealing means, and affording egressto the fluid through said dispensing unit while avoiding negativepressure within the container, thereby utilizing the original containerto insure and maintain the sterile condition of its fluid contentcontinuously from preparation through and including storage and use.

7. In fluid-handling apparatus, in combination, an apertured bushing forthe mouth of a fluid container, said bushing having inner and outerends, a tubular member received in and extending through the aperture ofthe bushing and projecting beyond the respective ends thereof to providea passage for the fluid, including an outlet beyond the outer end of thebushing and an inlet beyond the inner end of the latter butsubstantially spaced from the inner projecting end of the tubularmember, projecting means on the outer wall of the tubular member andengageable with the bushing ior positioning it relatively to the latter,and a longitudinal channel formationcarried by the tubular memberintermediate its ends and so positioned and of such length as to extendin the opposite directions beyond the bushing-engaged portion of thetube and at one end opening to atmosphere outwardly of said positioningmeans and adjacent the outer end of the bushing,- and at its other endprovided with a capillary valving formation for the passage of air andexclusion of the fluid by means of surface tension thereat.

8. A combined unitary fluid-dispensing and vacuum-relieving device forfluid-handling apparatus, comprising a main tubular member ofheat-resistant glass, said member having outer, intermediate and innerportions, said intermediate portion adapted for holding reception in abushing for the mouth of a fluid container, said outer portion having anexit for discharging fluid and said. inner portion having a closed innerend and having a fluid admitting aperture spaced from said closed endand communicating through the intermediate portion with said fluid exit,and integral channel means extending from a location outwardly of theintermediate portion to a location inwardly thereof and terminating atsaid latter location in a capiilary-valve-forming pasg sage for thecontrolled ingress of air during outflow of a fluid through said maintubular member.

9. A fluid dispensing element for fluid-handling apparatus comprising afluid outlet tube having an inner end closed to the fluid, anintermediate inlet for the fluid and an outlet for the latter at itsouter end portion, said tube having integrally associated with a wallthereof a longitudinal air channel provided at its end nearer the fluidinlet with a capillary-valve-forming passage for air to the exclusion ofthe fluid.

10. A fluid dispensing element for fluid-handling apparatus comprising afluid outlet tube including a container-entering portion havingintegrally incorporated with it a passage for communicating between theinside and outside of a container, said passage formed at its innerportion with a capillary air-inlet valving aperture proportioned andarranged to support by surface tension a calculated fluid column aboveit.

11. A fluid dispensing element in accordance with claim 10, wherein saidelement in its entirety is of one-piece heat-resistant glassconstruction.

12. A fluid dispensing element in accordance with claim 10, wherein theoutlet tube embodies a chamber for a fluid column adequate to create anegative pressure to break the balance and automatically to start theoutflow of fluid through the tube and ingress of air through thecapillaryvalved passage.

13. A dispensing vent-tube for liquid-handling containers, said tubebeing integrally formed of heat-resistant glass material and comprisinga main tubular element having one end open and formed for the attachingreception of a flexible conduit, said element including, in order fromsaid end, an outer portion, an intermediate portion for holdingreception by the container, and an inner portion for positioning withinthe container and having its inner end closed to fluid, a capillaryaperture in the wall of said inner por tion, an aperture in the wall ofsaid outer portion, a relatively small-dlametered tube within said maintubular element and establishing closed communication between saidapertures so as to provide a capillary valve for admission of air to thecontainer, and a liquid outlet in the wall oi said inner portion andspaced from the inner end thereof for the passage of liquid through saidmain tubular element and outwardly through its open end.

14. A dispensing vent-tube for liquid-handling containers, said tubebeing integrally formed of heat-resistant glass material and comprisinga main tubular element including a supporting portion and an inner orcontainer-entering portion, the end of said element outwardly of thesupporting portion being open and formed for the attaching reception ofa flexible conduit, said element having in the wall of its inner portionand below the inner end thereof a fluid admitting aperture communicatingwith said open end, and valved air-inlet means including a capillaryairadmitting valve on the container-entering portion of the tubularelement, an air-admission aperture positioned between said valve and theopen end of the tubular element, and a tubular passage providing closedcommunication between the air-admission aperture and the air-admittingvalve.

15. A dispensing tube in accordance with claim '14 wherein the device asa whole is of uniform cylindrical external conformation throughout savefor a reduced conduit-attaching portion at its open end and bead-likepositioning means intermediate its ends.

16. An integral one-piece dispensing device formed of heat-resistantglass and adapted for reception in a bushing in the mouth of a fluidcontainer, said device comprising a main tube having an intermediateportion for supporting reception by the bushing, a fluid-outletformation on the tube outwardly of the bushing position, a communicatingfluid-outlet aperture in the wall of the tube portion inwardly of saidbushing position, a capillary air-valving formation on said last-namedportion; and air passage means extending lengthwise the main tube andaffording closed communication between said capillary airvalvingformation and atmosphere.

CARL W. WALTER.

